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    Post approval services for pharmaceutical and biotech companies range from patient registries, Phase IV, Non interventional programs, pharmacovigilance etc. Services span to the entire life cycle of the drug post marketing with a keen focus on meeting challenges and addressing FDA/EMEA safety norms. The need for more safe and reliable drugs has led to robust post approval pharmacovigilance, leading to pressure on both, pharmaceutical and biopharmaceutical world. PV services helps the management

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    PHARMACOVIGILANCE / PRODUCT LIFECYCLE MANAGEMENT
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    01 Prague Scientific (1)

    02 Chiltern International Ltd (3)

    03 Covigilant LLC (2)

    04 Factory CRO (2)

    05 Greenleaf Health Inc (1)

    06 ICBio Clinical Research Pvt Ltd (1)

    07 Icon Plc (1)

    08 KAI Research (1)

    09 Nutrasource (1)

    10 PAREXEL International Corporation (4)

    11 PPD (3)

    12 Prorelix Research (1)

    13 TFS International AB (2)

    14 TransPerfect (1)

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    01 Canada (1)

    02 Czech Republic (1)

    03 India (2)

    04 Ireland (1)

    05 Sweden (2)

    06 U.S.A (14)

    07 United Kingdom (3)

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    Prague Scientific

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    Virtual BoothPrague Scientific offers services across different areas in development, regulatory & pharmacovigilance.
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    FULL SCALE PHARMACOVIGILANCE SERVICES

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    From early-stage development through the approval & launch of new products, Prague Scientific can assist with all regulatory needs across the entire product lifecycle. It offers full scale pharmacovigilance services with MA maintenance.

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    Pharma Service: Clinical Trials

    Category: Post Marketing

    Sub Category: Pharmacovigilance / Product Lifecycle Management

    Full Scale Pharmacovigilance Services

    CPhI Worldwide 2023

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    TransPerfect

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      PHARMACOVIGILANCE & SAFETY REPORTING

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      We enable global clinical development teams to rapidly translate and share pharmacovigilance information, such as SUSARs (suspected unexpected serious adverse reactions), SAEs (serious adverse events), hospitalization reports, and discharge summaries, within a centralized collaborative workspace.

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      Pharma Service: Clinical Trials

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      Sub Category: Pharmacovigilance / Product Lifecycle Management
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      Covigilant LLC

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        PERIODIC BENEFIT-RISK EVALUATION REPORTS (PBRER)

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        Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

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        Pharma Service: Clinical Trials

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        Sub Category: Pharmacovigilance / Product Lifecycle Management
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        PAREXEL International Corporation

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        LATE PHASE PARTNERSHIPS

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        PAREXEL's Peri/Post-Approval Services group of experts are dedicated to late phase research, offering a proven partnership model designed specifically for Late Phase.

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        Pharma Service: Clinical Trials

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        Sub Category: Pharmacovigilance / Product Lifecycle Management
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        Covigilant LLC

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          DEVELOPMENT SAFETY UPDATE REPORTS (DSUR)

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          Based on our extensive pharmacovigilance operations experience, we customize database software query tools to expand your data mining capabilities.

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          Pharma Service: Clinical Trials

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          Sub Category: Pharmacovigilance / Product Lifecycle Management
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          PPD

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          GLOBAL POST-APPROVAL SERVICES

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          Our clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements.

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          Pharma Service: Clinical Trials

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          Sub Category: Pharmacovigilance / Product Lifecycle Management
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          Factory CRO

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            POSTMARKETING SURVEILLANCE (PMS)

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            Factory has expertise in the design, conduct, analysis and reporting of PMS studies. Results from well-designed PMS studies can strengthen your marketing and sales efforts.

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            Pharma Service: Clinical Trials

            Category: Post Marketing

            Sub Category: Pharmacovigilance / Product Lifecycle Management
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            PAREXEL International Corporation

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            EPIDEMIOLOGY

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            At PAREXEL® we have senior Epidemiologists, and Statisticians, who have many years experience within the pharmaceutical industry providing solutions to the questions faced by our clients.

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            Pharma Service: Clinical Trials

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            Sub Category: Pharmacovigilance / Product Lifecycle Management
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            Icon Plc

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              PHARMACOVIGILANCE & RISK MANAGEMENT

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              Mapi provides a flexible, global pharmacovigilance service supporting regulatory compliance and management of patient safety issues.

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              Pharma Service: Clinical Trials

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              Sub Category: Pharmacovigilance / Product Lifecycle Management
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              Factory CRO

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                SAE / AE REPORTING

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                Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

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                Pharma Service: Clinical Trials

                Category: Post Marketing

                Sub Category: Pharmacovigilance / Product Lifecycle Management
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                Chiltern International Ltd

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                  PHARMACOVIGILANCE

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                  Our global Pharmacovigilance teams have the knowledge of local regulations, standards of care and cultural customs you need to identify and assess risks during your clinical trial — keeping patient safety a top priority. And, we have locations around the world to accommodate your trials wherever

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                  Pharma Service: Clinical Trials

                  Category: Post Marketing

                  Sub Category: Pharmacovigilance / Product Lifecycle Management
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                  Greenleaf Health Inc

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                    PRODUCT LIFECYCLE MANAGEMENT

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                    Greenleaf Health Inc. offers various services such as: Strategic guidance on FDA’s regulatory process; All aspects of product development; Premarket review; Postmarket safety requirements; Analysis of the market to identify potential competition.

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                    Pharma Service: Clinical Trials

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                    Sub Category: Pharmacovigilance / Product Lifecycle Management
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                    KAI Research

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                    SAFETY & PHARMACOVIGILANCE

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                    Our team of Drug Safety Associates (DSAs) provides clinical safety and pharmacovigilance support for biopharmaceuticals throughout the product life cycle.

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                    Pharma Service: Clinical Trials

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                    Sub Category: Pharmacovigilance / Product Lifecycle Management
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                    TFS International AB

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                      END-OF-TRIAL DECLARATIONS

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                      The TFS Regulatory Affairs Unit offers operational and strategic consulting services and has extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development to market authorization and product

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                      Pharma Service: Clinical Trials

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                      Sub Category: Pharmacovigilance / Product Lifecycle Management
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                      PPD

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                      PHARMACOVIGILANCE SERVICES

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                      Our experienced team of more than 700 pharmacovigilance professionals worldwide provide 24/7/365 availability and is fully focused on identifying and applying valuable insights based on pharmacovigilance needs.

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                      Pharma Service: Clinical Trials

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                      Sub Category: Pharmacovigilance / Product Lifecycle Management
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                      PAREXEL International Corporation

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                      DRUG SAFETY SERVICES

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                      PAREXEL understands that patient safety is at the heart of every company’s focus. This is why we are committed to delivering quality, integrated drug safety services across the full spectrum of the post-approval life cycle.

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                      Pharma Service: Clinical Trials

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                      Sub Category: Pharmacovigilance / Product Lifecycle Management
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                      PPD

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                      RISK MANAGEMENT & REMS STRATEGIES

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                      Our risk management team works in a matrix approach with departments across PPD. Experts in epidemiology, registries and observational studies, regulatory affairs, pharmacovigilance and call center operations provide support to REMS programs.

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                      Pharma Service: Clinical Trials

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                      Sub Category: Pharmacovigilance / Product Lifecycle Management
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                      Nutrasource

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                        MEDICAL AFFAIRS & PHARMACOVIGILANCE

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                        As part of our mission of ensuring sound scientific evidence in support of safe and effective products, our team places emphasis on product safety. We offer our clients a flexible suite of pharmacovigilance services during product development.

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                        Pharma Service: Clinical Trials

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                        Sub Category: Pharmacovigilance / Product Lifecycle Management
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                        Chiltern International Ltd

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                          SAFETY SURVEILLANCE & PREDICTIVE SIGNAL DETECTION

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                          Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

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                          Pharma Service: Clinical Trials

                          Category: Post Marketing

                          Sub Category: Pharmacovigilance / Product Lifecycle Management

                          </